DEPUY SPINE INC 5.5 EXP VERSE UNITIZED SET SCR; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
|
Back to Search Results |
|
Model Number 199721001 |
Device Problems
Device Slipped (1584); Migration (4003)
|
Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Date 01/01/2022 |
Event Type
Injury
|
Event Description
|
It was reported that on (b)(6) 2022 , the patient is being brought back for a 3rd surgery (2nd to address the same issue).The rod has once again migrated in the tulip head suggesting loosening.This report captures the reported 3rd surgery of rod migration, while related complaint (b)(4) captures the reported second surgery.This report is for one (1) 5.5 exp verse unitized set scr this is report 1 of 3 for complaint (b)(4).
|
|
Manufacturer Narrative
|
Additional device product codes: kwp;kwq;mnh;mni;osh.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.
|
|
Search Alerts/Recalls
|
|
|